In the development of pharmaceutical dosage forms, extreme attention is paid to the bioavailability of the active ingredients. Compressed products, also known as tablets, are frequently used for administering pharmaceutically active ingredients. To systematically release these active ingredients, in galenics, tablets with different compositions are provided which have a specific dissolution period, thus disintegration time.
Rapidly disintegrating tablets, so-called “oro-dispersible tablets” (ODT), are increasingly gaining in importance in the market. For this dosage form, a disintegration time in the oral cavity of less than 60 seconds, in particular less than 20 seconds is desired without the need of additional fluid intake.
The use of mixtures of 1,6-GPS (6-O-α-D-Glucopyranosyl-D-sorbitol) and 1,1-GPM (1-O-α-D-Glucopyranosyl-D-mannito) for producing tablets is known from DE 196 39 343 A1 and DE 199 43 491 A1.
Isomalt is a mixture of the two stereoisomers 1,6-GPS and 1,1-GPM. Isomalt is also known as Palatinit® or galenIQ®. Isomalt is obtained by hydrogenation of isomaltulose. In pharmacopoeias, isomalt is defined as an at least 98% pure mixture of 1,6-GPS and 1,1-GPM, wherein none of the two components is contained with less than 3% with respect to the dry substance.
Due to the sensory properties of isomalt, suitability for the use in tablets is principally given.
A technical problem underlying the present invention is the provision of isomalt-containing tablets with improved tablet hardness at the same pressing force. In particular, a technical problem underlying the invention is the provision of isomalt-containing tablets with reduced tablet hardness at the same pressing force.
Another technical problem underlying the present invention is the provision of isomalt-containing tablets with improved dissolution period at the same pressing force. In particular, a technical problem underlying the invention is the provision of isomalt-containing tablets with reduced dissolution period at the same pressing force.
Another technical problem underlying the present invention is the provision of methods for controlling the tablet hardness of isomalt-containing tablets. In particular, a technical problem underlying the invention is the provision of methods for reducing the tablet hardness of isomalt-containing tablets.
Another technical problem underlying the invention is the provision of methods for controlling the dissolution period of isomalt-containing tablets. In particular, a technical problem underlying the invention is the provision of methods for reducing the dissolution period of isomalt-containing tablets.
Another technical problem underlying the present invention is the provision of methods for producing isomalt-containing tablets which contain a small portion of magnesium stearate, in particular isomalt-containing tablets which contain no magnesium stearate, and isomalt-containing tablets themselves.